O-Two Medical Technologies, Inc. recalls O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 ---…

Recall date

June 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2705-2017

FDA classification

Class II

Brand / firm

O-Two Medical Technologies, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland

Why it was recalled

Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients